USP 797

Requirements Needed for Compounding Pharmacies Using USP 797

 

This 4-day course addresses the major requirements for compounding pharmacies for design, operations, microbiology, and aseptic procedures. Compounding pharmacies have had difficulties with these issues and this course will provide an understanding of the subjects. Hands-on activities will also be provided and will include cleaning, garmenting, monitoring, plus more.

Course outline     Who should attend?     Course materials     Instructors    Next date and location     Registration



Course outline

Day One

  1. What are the regulations?
    1. Basic definitions
    2. USP <795>
      1. Overview and what is required
    3. USP <797>
      1. Overview of the sections and what is required
    4. USP <800>
      1. Overview of the sections and what is required
    5. NIOSH HD list 
      1. How to find it
    6. FDA - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act-Draft
      1. The difference between 503a and 503b per FDA 
    7. FDA 503a license
      1. Review of the regulation and what is required 
    8. FDA 503b license
      1. Review of the regulation and what is required
      2. Overview of 21CFR 210/211
      3. FDA 503b guidance doc review
    9. 2004 aseptic guidance document
      1. Facility
      2. Validation
    10. FDA insanitary conditions draft

Day Two

  1. Facilities
    1. Understanding the cleanrooms — How does it work?
      1. Contamination control basics
      2. Cleanability and materials
      3. Equipment and fixtures
      4. Layouts
    2. Facility systems
      1. HVAC
      2. Water
    3. Design issues — How to correct them
      1. Placement of equipment and return air vents
      2. Laminar flow hoods and biosafety cabinets and placement of those items
      3. Flows — people, material, product, waste
      4. Surfaces
    4. Certification — What is required
      1. Initial tests
      2. Recurring tests
    5. Environmental monitoring/viable sampling
      1. What is it
      2. Air, surface, fingertip (gowning and post media fill) media fill
      3. Setting up a plan
    6. Airflow visualization 
      1. As-built
      2. At-rest
      3. Operational
    7. Aseptic technique
      1. Movement
      2. Contact 
      3. Product path/staging
      4. Supplementary equipment materials
      5. Validation/media fill

Day Three

  1. Environmental Monitoring
    1. Basic microbiology — Understanding contamination for cleanrooms
    2. Testing
      1. NVP
      2. Air viable
      3. Settling plates
      4. Surface sampling
    3. Compliance with regulations
      1. Locations
      2. Frequency
      3. Methods
      4. Equipment
    4. Sterility testing — USP methods
    5. Investigations and CAPAs
      1. How to write and perform
      2. What is needed

Day Four

  1. Operations
    1. People — Source of contamination
    2. Gowning
      1. Types
      2. Procedures
      3. Class and regulation
    3. Cleaning and sanitization
      1. Methods
      2. Disinfectants
      3. Testing
      4. Frequency
    4. Transfer of materials

Who should attend?

  • Compounding pharmacy owners
  • Compounding pharmacy managers
  • Pharmacy technicans
  • Cleanroom designers

 

Course materials

  • Copy of PowerPoint presentation in course binder
  • Copy of USP <797>

Continuing Education Units: 2.4 CEUs

 

Instructors

Gordon Ely
Jan Eudy
Kyle Mulder

 

Next date and location

No dates currently scheduled.